CoVClear Mutation Panel
Research Use Only (RUO)
The MiRXES CoVClear Mutation Panel is a real-time RT-PCR assay for the qualitative detection of key mutations in the receptor-binding domain (RBD) of the spike protein of the SARS-CoV-2 virus (N501Y, E484K, and L452R) from nasal specimens confirmed to be positive for SARS-CoV-2 by RT-PCR.
This tool can be used to identify COVID-19 positive patients who may have been infected by SARS-CoV-2 variants of concern (VOC), such as the Alpha (B.1.1.7 – UK) lineage, Beta (B.1.351 – South Africa) lineage, or Delta/Kappa (B.1.167 – India) lineage.
SARS-CoV-2 Variants Description
The World Health Organization (WHO) has defined a SARS-CoV-2 isolate as a variant of interest (VOI) if it is phenotypically changed compared to a reference isolate of has a genome with mutations that lead to amino acid changes associated with established or suspected phenotypic implications; AND has been identified to cause community transmission/multiple COVID-19 cases/clusters, or has been detected in multiple countries.
A VOI is further classified as a variant of concern (VOC) if, through a comparative assessment, it has been demonstrated to be associated with:
- Increase in transmissibility of detrimental change in COVID-19 epidemiology;
- Increase in virulence or change in clinical disease presentation; or
- Decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics.
WHO-designated variants of concern (VOCs) and selected variants of interest (VOIs), as of 31 May 2021.
First detected in
Mutation Panel Targets
Other characteristic spike mutations
69/70del, 144del, A570D, D614G, P681H, T716I, S982A, D1118H
D80A, D215G, 241/243del, K417N, D614G, A701V
B.22.214.171.124, alias P.1 (Gamma)
L18F, T20N, P26S, D138Y, R190S, K417T, D614G, H655Y, T1027I, V1176F
Q52R, A67V, 69/70del, 144del, D614G, Q677H, F888L
S13I, W152C, D614G
CoVClear Mutation Panel test kits are sold as individual mutation panels + a common reagent pack.
CoVClear Mutation Panel Reagent Pack
Reaction Master Mix, Enzyme Mix, Positive Control (WT+N), Negative Control
CoVClear Mutation Panel N501Y
Primer-Probe Mix (N501Y+N), Positive Control (N501Y+N)
CoVClear Mutation Panel E484K
Primer-Probe Mix (E484K+N), Positive Control (E484K+N)
CoVClear Mutation Panel L452R
Primer-Probe Mix (L452R+N), Positive Control (L452+N)
Research Use Only (RUO).